Kornimate/medical-research-clean huggingface dataset:
the use of tissue oxygen monitoring in critically injured patients

Conditions: Traumatic Brain Injury; Hemorrhagic Shock; Trauma

Summary: it is anticipated that the use of tissue oxygen monitoring to measure brain tissue oxygen and deltoid muscle oxygen will provide more precise information about focal brain ischemia and systemic hypoperfusion than current techniques and measures such as blood pressure, heart rate and intracranial pressure. understanding the relationship between tissue oxygen tension collected from the brain and deltoid muscle in critically injured patients could lead to a broader understanding of the important metabolic and cellular events that occur following severe injury and the changes induced by therapeutic interventions. furthermore, the use of interventions designed to improve tissue hypoxia, as measured by low brain or muscle tissue oxygen, may improve mortality or neurological recovery after systemic trauma or head trauma compared to current approaches that do not involve tissue metabolic monitoring.

this is a prospective, observational, cohort study designed to investigate metabolic changes in the brain and deltoid muscle of injured patients. study objectives are as follows: * to establish critical, abnormal levels of tissue oxygen in the brain (pbro2) and muscle (pmo2) of injured patients. * to correlate pbro2 with other currently available diagnostic measures used in head-injured patients, including icp, mean arterial blood pressure (map), cpp, sjo2, ct findings, neurological examinations, and clinical outcomes from traumatic brain injury. * to correlate pmo2 with base deficit measurements, standard physiologic variables, near infra-red oxygen levels, infectious complications, and outcomes in critically injured patients. investigators will enroll patients with multisystem trauma including brain injury. in addition to the results obtained from oxygen monitoring, other data collected prospectively will include: 1. baseline characteristics- mechanism of injury, arrival blood pressure and gcs, results of imaging procedures, age, gender, blood gas analysis, injuries and injury severity, and all operative procedures, 2. icu care - map, icp, cpp, base deficit, oxygen saturation, cvp, cardiac output, gcs scores, short-term outcome data, infectious complications and organ dysfunction. all physiological data will be downloaded automatically and continuously from the bedside monitor, ventilator, and oxygen monitors via a study-dedicated computer and customized software (aristein bioinformatics, palo alto, ca).

Eligibility criteria:
inclusion criteria: * age 18 years and older * intubated and assisted mechanical ventilation * traumatic brain injury requiring advanced neuromonitoring * abbreviated injury scale 3 or more in torso. abdomen, or extremities exclusion criteria: * age less than 18 years * pregnancy

Keywords: traumatic brain injury hemorrhagic shock multisystem trauma under resuscitation tissue oxygen monitoring
effects of denosumab on periprosthetic bone after total hip arthroplasty

Conditions: Osteoarthritis, Hip; Ambulation Difficulty

Summary: the primary objective is to study the effect of denosumab on bone mineral density, standardised uptake value and bone metabolism in patients with total hip arthroplasty. the primary hypothesis is to demonstrate that denosumab is superior to placebo.

a clinical study with 64 patients, age 35-65 years, with unilateral osteoarthritis of the hip, randomised to two groups of patients, either receiving denosumab or placebo the patients will operated with an uncemented total hip arthroplasty with a continuum acetabular cup with trabecular surface (tantalum) and longevity highly cross-linked polyethylene liner, zimmer, warsaw, in, usa, and a cfp femoral stem with titanium surface and a chrome cobalt 28 mm head, waldemar link, hamburg, germany. clinical outcome evaluated by harris hip score and eq-5d, bone mineral density by dxa, standardised uptake value of fluoride tracer, by pet/ct and biochemical markers for bone formation and bone resorption will be analyzed together with conventional radiology for implant position and fixation.

Eligibility criteria:
inclusion criteria: 1. male or female patient 35-65 years of age with an unilateral oah requiring a tha and a healthy contralateral hip 2. body weight ≤110 kg or body mass index (bmi) ≤35 kg/m2 3. living in the uppsala county 4. the eligible patients should have been given oral information, a written patient information and signed an informed consent exclusion criteria: 1. on or previously have had bone-specific treatment, e.g. bisphosphonates, raloxifene, parathyroid hormone, strontium ranelate, during the last five years 2. patients on systemical corticosteroid for more than 3 months should not be considered 3. patients with diagnosed malignant disease during the last five years or known to have metastasis from malignant disease should be excluded 4. patients with compromised general conditions and an american society of anesthesiologists, asa-score \>31 should not be regarded eligible 5. patients with known drug or alcohol abuse or regarded as socially dysfunctional, as judged by the investigator, should not be considered for the study 6. pregnant women or women planning for pregnancy or fertile women (premenopausal) without contraceptives should not be accepted for the study 7. patients that have been exposed frequently and/or have had large irradiation doses, as judged by the investigator, must not be included in the study. 8. enrolled in either another investigational drug study, in another investigational device study, or in another investigational study of an approved drug within 30 days prior to visit 1 of the current study 9. any condition or laboratory findings which in the opinion of the investigator makes the patient unsuitable for inclusion (for example claustrophobia)

Keywords: osteoarthritis of the hip uncemented total hip arthroplasty dxa bmd pet ct biochemical bone markers
assessment and prevention of pain during ovarian stimulation in patients with endometriosis

Conditions: Endometriosis; Ovarian Hyperstimulation

Summary: randomized double blinded placebo-controlled trial to evaluate the impact of ovarian hyperstimulation on endometriosis-related symptoms and to evaluate the impact of letrozole use during ovarian hyperstimulation with respect to endometriosis-related symptoms, embryo/egg quality and quantity, and pregnancy rates.

randomized double blinded placebo-controlled trial to evaluate: (1) the impact of letrozole use during ovarian hyperstimulation with respect to endometriosis-related symptoms, embryo/egg quality and quantity, and pregnancy rates, (2) the impact of ovarian hyperstimulation on endometriosis-related symptoms. there will be a total of 60 participants, 20 participants with endometriosis randomized to the placebo group, 20 participants with endometriosis randomized to the letrozole group and 20 control patients with no history of endometriosis. letrozole and placebo medication will be started on the first day of gonadotropin injections and continued until the day of trigger shot. medication will be restarted the night of egg retrieval and continued for 2 weeks post retrieval. endometriosis associated symptoms will be evaluated using a survey modeled after the clinical survey developed by the world endometriosis research foundation endometriosis phenome and biobanking harmonisation project. surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval.

Eligibility criteria:
inclusion criteria: * age 18-42 years * planning to undergo controlled ovarian hyperstimulation * prior diagnosis of endometriosis by one of the following: (1) surgical diagnosis (2) endometrioma on pelvic ultrasound * planning to freeze all retrieved oocytes/embryos prior to transfer exclusion criteria: * hypersensitivity to letrozole * any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results

Keywords: endometriosis letrozole
transfusion for major haemorrhage in trauma - characteristics and outcomes

Conditions: Trauma; Hemorrhage; Shock, Traumatic; Acute Coagulopathy

Summary: background: trauma is the leading cause of death in young adults worldwide and the most common causes of mortality are haemorrhage and brain injury. about 40% of trauma related deaths are due to massive haemorrhage and approximately 30% of trauma patients have an associated trauma induced coagulopathy. in order to improve outcome, the optimal care for the bleeding patient need to be further understood. aim: the overall aim of this project is to evaluate characteristics and outcomes in patients receiving blood transfusion in the early phase after major trauma at a level 1 trauma center in sweden. the specific aims are: i) to describe outcome, characteristics and effects on the coagulation system in patients receiving early blood transfusion compared to those not receiving transfusion in the early phase. ii) to describe outcome, characteristics and effects on the coagulation system in patients receiving prehospital blood transfusion compared to patients where transfusion is initiated in the trauma unit. iii) to describe the effect from concurrent treatment with procoagulant drugs and intravenous fluids on outcome, characteristics and effects on the coagulation system in patients receiving blood transfusion after major trauma. method: this is an observational study of trauma patients admitted to the trauma unit at the karolinska university hospital solna, stockholm, sweden. data from patients receiving blood transfusion (erythrocytes, plasma or whole blood) in the early phase of the resuscitation will be collected. all patients receiving transfusion within two hours from arrival will be included. data on trauma details, injuries, physiological parameters, coagulations tests and treatment will be collected prospectively and from existing registries. the control group will consist of patients not receiving transfusion during the first two hours of care.


Eligibility criteria:
inclusion criteria: * all trauma patients admitted to the trauma unit at the karolinska university hospital solna. exclusion criteria: * patients with injuries från hanging, drowning, burns or smoke inhalation.
a phase 3 study of obexelimab in patients with igg4-related disease

Conditions: IgG4 Related Disease

Summary: this study aims to examine the efficacy and safety of obexelimab for the prevention of flare of igg4-related disease (igg4-rd)

this study consists of a 1-year randomized control period (rcp), followed by an additional 2-year open label extension (ole) period. to enter the screening period (day -28 to day -1), patients must have active igg4-rd signs/symptoms (i.e., flare) that require steroid therapy. on day 1, patients will be randomized in a ratio of 1:1 to receive either obexelimab or placebo administered as subcutaneous (sc) injections. all patients will begin a steroid taper on day 1 to discontinuation by week 8. patients will be monitored for flares during scheduled in clinic visits and any unscheduled visits. the primary endpoint is time to first igg4-rd flare that requires initiation of rescue therapy in the opinion of the investigator and the adjudication committee (ac). following the 52-week rcp, patients will have the opportunity to continue in an ole period where all patients will receive obexelimab. patients who do not wish to enroll into the ole period will return for an in-clinic safety follow-up visit 8 weeks after the week 52 visit (i.e., week 60). including screening and follow-up, the maximum duration of participation in this study for an individual patient is 172 weeks (i.e., 28-day screening, 52-week rcp, 104-week ole, and an 12-week follow-up).

Eligibility criteria:
inclusion criteria: 1. males and females, ≥ 18 years of age 2. clinical diagnosis of igg4-rd 3. patients must meet the 2019 acr/eular classification criteria for igg4-rd 4. patients must have active igg4-rd signs/symptoms (i.e., flare) that require the initiation of gc therapy or the increase in background long-term gc therapy 5. other inclusion criteria apply exclusion criteria: 1. has disease in only 1 organ system whose primary manifestation is fibrosis 2. has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening 3. has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than gcs within the 4 weeks prior to screening 4. has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or \< 5 half-lives of the investigational treatment, whichever is shorter, prior to screening 5. has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening 6. active tuberculosis or high risk for tuberculosis; hepatitis c infection in absence of curative treatment; evidence of hepatitis b infection 7. use of b cell depleting or targeting agents within 6 months of randomization 8. other exclusion criteria apply

Keywords: igg4 igg4-rd
the strength study: shapely sisters targeting realistic exercise and nutrition goals through healthy habits

Conditions: Obesity

Summary: this study evaluates the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (bmi \> 40.0) african american women.

stress has been identified as a major barrier to engaging in healthy lifestyle behaviors (e.g. diet and exercise) among african american women. african american women consistently lose less weight than their caucasian counterparts in weight loss interventions. one reason for this disparity may be due to the failure of most weight loss interventions to address stress management adequately or in a culturally competent way. the purpose of this study is to evaluate the efficacy of a stress-focused tailored weight loss intervention compared to a standard weight loss intervention on weight loss in severely obese (bmi \> 40.0) african american women. the stress-focused weight loss intervention will incorporate stress management content throughout the entire intervention and will include content that is culturally tailored. the standard weight loss intervention will cover stress management techniques during one of the 14 sessions and the material will be more generic in nature (e.g. not culturally tailored).

Eligibility criteria:
inclusion criteria: * african american (self-identified) * female * bmi \> 40 kg/m2 * access to internet connection and phone for personal use exclusion criteria: * unable to walk without the use of an assistance device * failure to pass the physical activity readiness questionnaire (par-q) or unable to attain medical clearance from their doctor * substance abuse within past two years * schizophrenia * currently pregnant, pregnant within the past 6 months or plans to become pregnant in the next 6 months * history of malignancy other than non-melanoma skin cancer, that has not been in remission or cured surgically for \> 5 years * participation in a weight loss program in the past 12 months * \> 5% loss of body weight within the past 6 months * bariatric surgery recipient * heart attack in the past 6 months * stroke within the past 6 months note: participants who "fail" the par-q will be required to obtain medical clearance from their medical provider

Keywords: african american, women weight loss
epidemiology and co-reactivity of novel surfactant allergens

Conditions: Allergic Contact Dermatitis

Summary: the primary objectives of this study are to identify positivity rates to three novel surfactants (ingredients used in soaps, detergents, and other cleansers that serve to lower the surface tension of the skin and remove debris) and co-reactivity with other surfactants in patients with known surfactant sensitivity on skin patch testing. the investigators hypothesize that subjects who previously tested positive to known allergenic surfactants (cocamidopropyl betaine, stearamidopropyl dimethylamine, dimethylaminopropylamine, coconut diethanolamide, oleamidopropyl dimethylamine, and decyl glucoside) may demonstrate co-reactivity to the three novel surfactant sensitizers (sodium lauroyl sarcosinate, isostearmidopropyl morpholine lactate, and disodium lauroamphodiacetate) on skin patch testing.


Eligibility criteria:
inclusion criteria: 1. documentation of a previous contact allergy to one or more surfactant(s) on our screening series including: * cocamidopropyl betaine * stearamidopropyl dimethylamine * dimethylaminopropylamine * coconut diethanolamide * oleamidopropyl dimethylamine, and * decyl glucoside 2. age 18 years or greater. exclusion criteria: 1. pregnant or lactating women 2. use of systemic therapy (corticosteroid, immunosuppressive agents, cytostatics, pentoxifylline, leukotriene antagonists or other medication known or suspected to have an effect of acd) within two weeks prior to participation 3. use of intramuscular steroids in the last month. 4. phototherapy (puva or uvb) within two weeks prior to participation. 5. direct sunlight or tanning booth use to the back within the two weeks prior to participation.
exploratory study of aerosol inhalation of fb2001 for post-exposure prophylaxis of covid-19 close contacts

Conditions: Close Contact Transmission

Summary: this is a single-arm, open-label, dose ramp-up exploratory clinical trial to evaluate the efficacy, safety and tolerance of aerosol inhalation of fb2001 as post-exposure prophylaxis among close contacts of covid-19 patients. this study will enroll 20 to 60 close contacts of covid-19 patients aging 18 to 65 years. after signing the informed consent form, the qualified subjects will be given fb2001 once or twice daily.


Eligibility criteria:
inclusion criteria: 1. male or female individuals aged 18-65 years. 2. covid-19 close contacts determined by epidemiological investigation (living in the same room within 72 hours before screening with individuals having positive nucleic acid amplification test for sars-cov-2 ). 3. having two consecutive negative nucleic acid tests within 72 hours before enrollment. 4. participants of childbearing age must agree to use a highly effective method of contraception. 5. sign the informed consent form. exclusion criteria: 1. pregnant women. 2. participants who have history of prior drug allergy or are vulnerable to allergy. 3. participants who infected with sars-cov-2 within previous 6 months. 4. fever (body temperature \> 38 ℃), frequent cough and other symptoms suggestive of covid-19 upon screening. 5. participants with a history of asthma or chronic obstructive pulmonary disease. 6. participants with known history of active liver disease, acute kidney disease or chronic kidney disease. 7. participants with known history of stroke (except cavity infarction), serious heart disease or myocardial infarction. 8. participants with known diagnosis of alzheimer's disease, parkinson's disease or tumor (except for radical tumor resection). 9. blood pressure \>180/100mmhg at screening. 10. participated in other interventional studies within previous 6 months. 11. uptaking cyp3a4/5 strong inducers or inhibitors (rifampicin, phenytoin, carbamazepine, st. john's wort, clarithromycin, itraconazole, ketoconazole, ritonavir, cobicistat, darunavir, atazanavir, lopinavir, nelmatevir, nefazodone, etc.). 12. participants who need to use other anti-sars-cov-2 therapeutic drugs during the study period. 13. other conditions are considered unsuitable to participate in the researcher after evaluation by the researcher.
intravesical gem/doce in patients with nmibc

Conditions: Urinary Bladder Cancer

Summary: intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (nmibc) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. for high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical bacillus calmette-guérin (bcg) can be effective as first-line; nevertheless, the response rate to bcg is suboptimal with many patients failing treatment. following bcg-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. recent shortages of bcg have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. at the university of arizona cancer center, the use of intravesical gemcitabine + docetaxel (gem/doce) is considered as standard treatment for patients with non-invasive bladder cancer who are unable to get bcg or are bcg-resistant. the role of gemcitabine as first-line treatment for nmibc is poorly understood. the purpose of this study is to gain a better understanding of the use of gemcitabine + docetaxel intravesical chemotherapy for non-muscle invasive bladder cancer.


Eligibility criteria:
inclusion criteria: 1. patients able to consent in english or spanish; provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female ages ≥18 years. 4. patients with intermediate or high-risk non-muscle-invasive uc of the bladder and no previous bcg treatment. 1. histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (ta, t1, or tis stage) on transurethral resection of bladder tumor (turbt) must be obtained within 180 days of registration. or patients with a high-grade recurrence after 24 months since last dose of bcg. 6. eastern cooperative oncology group (ecog) performance status grade 0-2. 7. post-transurethral bladder tumor resection. 8. evidence of post-menopausal status or negative urinary pregnancy test of female pre-menopausal patients is required. women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. exclusion criteria: 1. known hypersensitivity reaction to gemcitabine and/or docetaxel. 2. clinical t2 or higher stage uc of the bladder. 3. histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure cis of the bladder. 4. active malignancies other than the disease being treated under study. 5. subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage. 6. pregnant or breast-feeding women. 7. has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.

Keywords: bacillus calmette-guérin (bcg) nonmuscle invasive bladder cancer (nmibc) intravesical immunotherapy post-transurethral resection